Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data
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Purpose
We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.
| Condition |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data |
- The analysis for the progressive castrate mets disease population consists of two analytical steps. The first step involved the development of a predictive model of pt survival using supervised multivariate analytical (SMA)techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
In a first analytical step, using only the clinical and pathological variables used in the original clinical mets castrate disease nomogram as inputs, supervised multivariate analytical techniques (SMA) were used to generate a new predictive model for patient survival. A similar approach will then be used to analyze a second group of approximately 223 pts in the state of a rising PSA14 after surgery or radiation therapy treated on a sequential series of IRB approved trials testing conjugate vaccines also consented on IRB protocol 90-40.
| Estimated Enrollment: | 0 |
| Study Start Date: | May 2004 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Stage 1 - Population: Progressive Metastatic Disease Stage 2 - Population: Rising PSA
Inclusion Criteria:
Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.
For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..
Exclusion Criteria:
For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4
• (MSKCC - add reference if publication available for rising PSA patients)
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Howard I Scher, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Howard I. Scher, MD, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00578409 History of Changes |
| Other Study ID Numbers: | 04-062 |
| Study First Received: | December 19, 2007 |
| Last Updated: | April 27, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
castration resistant prostate cancer progressive castrate metastatic prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013